Model Number 1219-28-144 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Adhesion(s) (1695); Hematoma (1884); Pain (1994); Joint Dislocation (2374); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Date 07/15/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Patient had revision of the left hip prosthesis ((b)(6) 2020) for hip dysplasia, with a previous 5cm shortening, and in surgery they perform a femoral osteotomy to reduce the prosthesis.He refers from the immediate post op to presented intense pain in the left hip, which does not improve with analgesics, limits his gait and movements of the hip in total hip replacement for dysplasia, hospitalized for dislocation of the hip prosthesis, currently with traction of soft tissues with 3 kg of weight, patient who is afebrile, painless, with shortening, already scheduled for surgery.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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